F.D.A. | U.S. drug recalls common, not well publicized, study finds

Published June 05, 2012

Reuters

The U.S. Food and Drug Administration (FDA) recalls potentially harmful drugs about once every month, but they could be doing a better job of letting doctors and patients know about them, says a new study.

Over an eight-year span, researchers found that the FDA failed to send notifications for one in five of the most serious recalls through its two electronic systems used to alert doctors and the public.

The so called Class I recalls, according to the FDA, are issued for drugs that, if taken, have the potential to cause “serious adverse health consequences or death.”

The 2008 contamination of the blood thinner heparin, one of the most notable and recent examples of a Class I recall, resulted in serious reactions and some deaths in dialysis patients. That recall, according to one of the study’s authors, was reported.

“I think a good system would indicate all of the Class I recalls, and it wouldn’t necessarily communicate recalls the FDA deems less important, such as Class II and Class III,” said Joshua Gagne, from Brigham and Women’s Hospital in Boston.

Between 2004 and 2011, Gagne and his fellow researchers counted more than 1,700 drug recalls listed in the FDA’s enforcement reports. Of those, 91 were serious Class I recalls.

During that time, the FDA issued about 2,900 announcements through the Recall Alert System, which sends notifications to subscribers about recalled drugs and products. The system, however, only sent alerts for 55 of the 91 Class I recalls.

MedWatch, another system used by the FDA to report drug recall information, sent alerts for 18 of the remaining recalls. Another 18 — or one-fifth — of the Class I recalls were never reported through either system.

“Despite recent efforts by the FDA to address the drug recall burden, health care providers may be inadequately informed about clinically important recalls that threaten patient safety,” wrote the authors in a letter to the Archives of Internal Medicine on Monday.

An FDA spokesperson told Reuters Health there are a number of ways the agency communicates with doctors, but she wasn’t able to say why notifications weren’t sent in these 18 cases.

Active tracking

There’s no way, according to Gagne, to know if the lack of notifications were linked to any patient harm.

He added that the FDA has moved to address communication problems, including recall notifications.

“It’s certainly on their radar and they’re constantly starting initiatives to address it, but there is still room for improvement,” he said.

Dr. Lisa Schwartz, co-director of the Center for Medicine and Media at the Dartmouth Institute in Lebanon, New Hampshire, told Reuters Health that the FDA should try hard to let everyone know about Class I drug recalls until there is a system that allows the agency to track the recalled drugs.

“It’s unclear why it shouldn’t be 100 percent of the time they’re notifying people on both systems,” said Schwartz, who was not involved in the new study.

Gagne and his fellow researchers echoed Schwartz’s call for an active tracking system.

“The tracking could all be computerized so pharmacies can know which bottles the recalled products came from,” said Gagne.

Until then, he told Reuters Health that there are other ways doctors can find out about recalls. One way is for the drug companies to send letters directly to doctors. His team, however, was not able to look into those methods of notification.

But ultimately, Gagne said, the FDA needs “a more specific system that only communicates all of the Class I information.”

The current alert systems, according to the researchers, not only reports Class I recall information, but information on — among other things — device, food and veterinary drug recalls.

The FDA’s automatic email notices about recalls are available at 1.usa.gov/MbBGEu or on Twitter: @FDArecalls.